Device Recall Cervical Plate

  • Modelo / Serial
    Catalog Number 05-100-03-0042, Lot # 68122001.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution to Florida only.
  • Descripción del producto
    Exactech Ambassador Cervical Plate System || The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA